Image

A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression

Study on VNS Therapy® for treatment-resistant depression safety and effectiveness.

Recruiting
18 years and older
All
Phase N/A

This study tests if a special treatment called **VNS Therapy** is safe and works well for people with **Treatment-Resistant Depression** (TRD). VNS stands for **Vagus Nerve Stimulation**, a therapy that uses a small device to send electrical signals to the brain. People in the study are divided into two groups: one gets the VNS therapy, and the other does not. The main part of the study lasts for 12 months, but participants may continue in a longer study for up to 5 years.

**Key Points:**

  • Participants must have had depression for at least 2 years or 4 episodes and failed at least 4 treatments.
  • The initial study period is 12 months, with a potential to continue for 5 years.
  • Participants should not have other serious mental health disorders or be on investigational treatments.

This study is important to see if VNS Therapy can help people who haven't found relief from other treatments. If you qualify, you may get the chance to try a new kind of therapy that might help with your depression symptoms.

Study details
    Treatment Resistant Depression

NCT03887715

LivaNova

22 December 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

  Other languages supported:

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.